Home Applications 078396 Application 078396
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM INJECTABLE;INJECTION EQ 0.5MG BASE/VIAL No No 002 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM INJECTABLE;INJECTION EQ 1.5MG BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078396-001 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION 2008-04-23 A078396-002 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION 2008-04-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A078396-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 2008-04-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078396-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 2008-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078396-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 2008-04-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078396-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 2008-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078396-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 2008-04-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078396-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 2008-04-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078396-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION 2008-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078396-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION 2008-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-1985 Epoprostenol Sodium Epoprostenol Sodium Teva Parenteral Medicines, Inc. ANDA Current 0703-1985 Epoprostenol Sodium Epoprostenol Sodium Teva Parenteral Medicines, Inc. ANDA Current 0703-1985 Epoprostenol Sodium Epoprostenol Sodium Teva Parenteral Medicines, Inc. ANDA Current 0703-1995 Epoprostenol Sodium Epoprostenol Sodium Teva Parenteral Medicines, Inc. ANDA Current 0703-1995 Epoprostenol Sodium Epoprostenol Sodium Teva Parenteral Medicines, Inc. ANDA Current 0703-1995 Epoprostenol Sodium Epoprostenol Sodium Teva Parenteral Medicines, Inc. ANDA Current 0703-9258 Sterile Diluent Sterile Diluent Teva Parenteral Medicines, Inc. ANDA Current 0703-9258 Sterile Diluent Sterile Diluent Teva Parenteral Medicines, Inc. ANDA Current 0703-9258 Sterile Diluent Sterile Diluent Teva Parenteral Medicines, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9154 ORIG 2008-04-28